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FDA 510(k)

Picore

K-Number: K212082 · 2021-10-06

ApplicantBio-Med USA, Inc.
Decision Date2021-10-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Picore is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med USA, Inc.. It received FDA 510(k) clearance on 2021-10-06 under 510(k) number K212082. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Picore?

Picore is a medical device that received FDA 510(k) clearance on 2021-10-06. The listed applicant is Bio-Med USA, Inc.. The 510(k) number is K212082.

When did Picore receive FDA 510(k) clearance?

Picore received FDA 510(k) clearance on 2021-10-06, under 510(k) number K212082.

Who is the listed applicant for Picore?

The FDA 510(k) record lists Bio-Med USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Picore?

The FDA product code for Picore is GEX. This falls under the Gastroenterology category.

Other records listing Bio-Med USA, Inc. as applicant

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Related Devices (Code: GEX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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